'Individual case safety reports' presentation slideshows

FDA Update

FDA Update. Randy Levin, MD and William A. Hess, CAPT USPHS HL7 16th Annual Working Group Meeting Baltimore, MD October 2002. FDA Update. New Ingredient Dictionary Pharmaceutical Dosage Forms E2BM Data Elements Labeling Effort NDC. FDA Update. New Ingredient Dictionary History Need

768 views • 63 slides

The Future of Pharmacovigilance: Hot Issues on the Horizon in the EU

541 views • 38 slides

New Medicines: too early/too late?

357 views • 29 slides

New Medicines: too early/too late?

402 views • 29 slides

SAFETY MONITORING IN CLINICAL TRIALS

SAFETY MONITORING IN CLINICAL TRIALS. Dr. S. K. Gupta Dean & Director General Institute of Clinical Research India New Delhi. Introduction.

19.08k views • 26 slides

Chris Holmes Principal, WCI Consulting Ltd

Pharmacovigilance and Drug Safety: Top 10 Issues facing Compliance and Legal Pharmaceutical Regulatory Compliance Congress and Best Practices Forum November 8 th 2007 Washington DC. Chris Holmes Principal, WCI Consulting Ltd. Contents. Pharmacovigilance (PV) environment Best Practices Forum

566 views • 25 slides

? OTC LOVASTATIN

? OTC LOVASTATIN. Jesse M. Polansky M.D., M.P.H. jmpqz@yahoo.com Representing self. ? EFFICACY PRIMARY PREVENTION. FDA Statistical Review: Uncertainty in post-hoc AFSCAPs analysis (low HDL population vs OTC population) Absolute vs. Relative Risk Reduction

225 views • 11 slides